Regulatory Affairs Manager at IQVIA

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor's Degree in Life Science or related discipline (required) or Master's Degree in Life Science or related discipline
At least 8 years of relevant experience
Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws, and related guidelines
Specific regulatory or technical expertise and sufficient knowledge of managing regulatory projects and deliverables on a time-bound basis
Expert in planning and delivering work on time while maintaining quality parameters
Knowledge of regulatory procedures in the appropriate region, particularly marketing authorization transfers and relevant cross-functional dependencies
Good working knowledge of regional regulatory intelligence
Ability to work closely with client regional heads to determine MAT, Regulatory Publishing & submission strategy and execute marketing authorization transfer plans
Good understanding of pharmacovigilance activities relevant to transfer of marketing authorization
Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Strong software and computer skills, including Microsoft Office, publishing applications, and tools
Ability to work on several projects with direction from senior staff as appropriate
Ability to follow standard operating procedures consistently and provide independent thought for process improvements
Ability to make decisions on discrete tasks under senior supervision
Advanced knowledge within a specific discipline gained through extensive work experience and/or education
Experience in regulatory strategy, determination of documentation requirements, timelines, and budgets for MATs and Publishing projects
Project leadership experience
Ability to make adjustments or recommend enhancements in systems and processes to solve problems or improve effectiveness

Responsibilities

Acts as a Regulatory Team Leader on complex projects, which may include technical writing, or acts as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate
Competently writes regulatory and/or technical documents with minimal review by senior staff
Establishes relationships with many customers; may meet face-to-face without the rest of the team to discuss regulatory issues and present lessons learned, adopting a proactive and flexible approach to resolve issues
Undertakes detailed review and management of budgets related to projects, including out-of-scope activities; ensures revenue is recognized and challenges when appropriate, seeking guidance from senior staff as needed
May give guidance to junior colleagues, including feedback on the quality of technical documents, and assist in their training and development
May present to clients at bid defense meetings by phone or in person for a range of regulatory deliverables, at the discretion of senior staff
May write new regulatory standard operating procedures, propose revisions, or act as reviewer for regulatory standard operating procedures, as assigned
May be involved in a Regulatory and/or IQVIA Initiative
Performs other tasks or assignments as delegated by Regulatory management
May manage meetings with Regulatory Agencies
May be assigned as Reviewer and/or Approver for Regulatory standard operating procedures or cross-functional standard operating procedures owned by other operations
May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative
Performs other duties as business needs require

Skills

Regulatory Affairs

Technical Writing

Project Management

Budget Management

SOP Development

Client Relationship Management

Agency Meetings

Bid Defense

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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